![LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR BB BLUR BROAD SPECTRUM SPF 20 SUNSCREEN (TITANIUM DIOXIDE) CREAM [L'OREAL USA PRODUCTS INC]](https://medic.hrt.org//dailymed/images/831801b5-97fe-481d-8e02-cdbfbd5d72b5/LRPEffaclarBBblur.jpg)
| NDC | 49967-022-01, 49967-022-02 |
| Set ID | 831801b5-97fe-481d-8e02-cdbfbd5d72b5 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | L'Oreal USA Products Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
For sunscreen use:
● apply generously 15 minutes before sun exposure
● reapply at least every 2 hours
● use a water resistant sunscreen if swimming or sweating
● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
● limit time in the sun, especially from 10 a.m. – 2 p.m.
● wear long-sleeved shirts, pants, hats, and sunglasses
● children under 6 months of age: Ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR BB BLUR BROAD SPECTRUM SPF 20 SUNSCREEN
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-022 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 106.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) UNDECANE (UNII: JV0QT00NUE) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) TRIDECANE (UNII: A3LZF0L939) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PERLITE (UNII: 0SG101ZGK9) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) RETINYL LINOLEATE (UNII: 61911N8D6W) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-022-01 1 in 1 CARTON 08/20/2015 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-022-02 1 mL in 1 PACKET; Type 0: Not a Combination Product 08/20/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/20/2015 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations BCM Cosmetique SAS 275359578 manufacture(49967-022) , analysis(49967-022) , pack(49967-022) Establishment Name Address ID/FEI Business Operations Cosmetique Active Production 282658798 analysis(49967-022) , manufacture(49967-022) Establishment Name Address ID/FEI Business Operations Socoplan 276221405 pack(49967-022)
